Staff Catheter Engineer

Stryker Corporation; Waltham (MA); On-site; Confidential; Full time

Job summary

Stryker Corporation in Waltham, MA is seeking a Staff Catheter Engineer to drive the design, development, and commercialization of disposable catheter technologies for intravascular lithotripsy. You will work across concept generation, prototype development, verification, validation, and manufacturing transfer to ensure safe, effective devices.

Responsibilities include designing balloon catheter systems, creating robust design documentation, performing V&V testing, and supporting risk management

Qualifications

• Bachelor's degree in Mechanical/Biomedical/Materials engineering required.
• Minimum 4 years of medical device product development experience.
• Experience designing catheter systems including prototypes, assembly or testing.
• Proficiency with SolidWorks and FDA/ISO design controls.
• Experience in ISO Class 7/8 cleanroom environments is preferred.

Responsibilities

• Design and develop disposable balloon catheter systems and platforms.
• Create catheter concepts meeting clinical, manufacturability, and regulatory needs.
• Develop drawings, specifications, and design docs in SolidWorks.
• Plan and execute verification and validation testing per standards.
• Investigate issues, perform root cause analysis, implement CAPA.
• Support regulatory submissions and design reviews.

Skills

SolidWorks

Design Controls

Catheter design

Education

Bachelor’s degree in Mechanical Engineering, Biomedical Engineering, or Materials Engineering

Tools

Balloon forming equipment

Extrusion equipment

Braiding and Coiling machinery

Laser processing equipment

Job description

## Staff Catheter EngineerApplylocations: Waltham, Massachusettstime type: Full timeposted on: Posted Yesterdayjob requisition id: R569263Work Flexibility: Onsite**Staff Catheter Engineer***Waltham, MA*Join a team focused on the design, development, and commercialization of innovative disposable catheter technologies in the intravascular lithotripsy market. As a Staff Catheter Engineer, you will contribute across the full product development lifecycle, from concept generation and prototype development through verification, validation, and manufacturing transfer. This role combines hands-on engineering, technical problem-solving, and cross-functional collaboration to support the delivery of safe, effective, and manufacturable medical devices.**What You Will Do*** Design and develop disposable balloon catheter systems and catheter platforms for new and existing applications.* Create catheter concepts that meet clinical, functional, manufacturability, and regulatory requirements.* Develop engineering drawings, specifications, and design documentation using SolidWorks and established documentation practices.* Select and evaluate catheter materials, including polymers, balloons, shafts, braids, coils, adhesives, and marker bands.* Develop and optimize catheter manufacturing and assembly processes, including balloon bonding, thermal forming, lamination, tip forming, adhesive bonding, and laser processing.* Plan, execute, and document verification and validation testing to confirm compliance with design requirements, applicable standards, and regulatory expectations.* Investigate design and process issues, perform root cause analysis, and implement corrective actions to improve product performance, manufacturability, and reliability.* Support risk management, design reviews, supplier qualification activities, manufacturing transfer, and regulatory submissions through technical documentation and engineering analysis.**What You Will Need****Required Qualifications*** Bachelor’s degree in Mechanical Engineering, Biomedical Engineering, Materials Engineering, or a related engineering discipline.* Minimum 4 years of experience in medical device product development.* Experience designing catheter systems, including prototype development, assembly, or testing activities.* Proficiency with SolidWorks.* Experience applying Design Controls within FDA and ISO requirements.**Preferred Qualifications*** Experience with balloon catheter technologies, balloon forming, or catheter manufacturing processes.* Experience with extrusion, braiding, coiling, laser processing, or related catheter manufacturing methods.* Experience working in ISO Class 7 or ISO Class 8 cleanroom environments.* Training or experience in statistical analysis, Design of Experiments (DOE), Design Failure Mode and Effects Analysis (DFMEA), or Process Failure Mode and Effects Analysis (PFMEA).* $107,200 - $178,600 USD AnnualTravel Percentage: 10%Stryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status. Stryker is an EO employer – M/F/Veteran/Disability.Stryker Corporation will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information.